Auditory Diagnostics and Error-based Treatment

Deafness, Bilateral Clinical Trial

— AuDiET  

Official title:

Auditory Diagnostics and Error-based Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307952
• Other study ID #: 2022-13495
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: December 2024

Study information

• Verified date: June 2023
• Source: Radboud University Medical Center
• Contact: Wendy Huinck, PhD
• Phone: +31243613506
• Email: Wendy.Huinck[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.

The participants will undergo 1 visit lasting approximately 2 hours at the Radboud university medical center's ENT department, where they will undergo a series of diagnostic tests. Some of the participants will also be asked to self-administer additional tests using a Windows tablet.

Based on the outcomes of speech recognition tests in quiet at the first visit, the participants will be called for follow-up interventions concerning both the fitting of their CI and personalized auditory training based on their personal error patterns. These interventions will take place over the course of approximately 5 months and will be made up of three follow-up visits and a period of self-administered training through a mobile application on a tablet.

One final follow-up visit will check whether any changes from the interventions are retained after four weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult (over 18 years old at the time of inclusion )

• Post-lingually deafened (the subject had a good mastery of spoken language before onset of deafness)

• Native Dutch speaker

• Implanted, either unilaterally or bilaterally, with a Cochlear Implant manufactured by Cochlear Ltd (i.e., a Nucleus ® implant).

• Implanted with one of the following implants: CI422, CI512, CI522, CI532, CI24M, CI24R, CI24RE.

• Implanted for at least 12 months.

Exclusion Criteria:

• Known abnormally formed cochlea

• Known pre-implantation ossification of the cochlea

• Severe cognitive disorders affecting their ability to understand spoken language

• Intense facial nerve stimulation

• Unaddressed electrode tip foldover

• More than 4 electrodes deactivated because of malfunction (open/short circuit) or lack of response

• Additional illnesses or handicaps that could impact ability to participate in study, at the clinician's discretion.

Related Conditions & MeSH terms

• Deafness
• Deafness, Bilateral
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

Diagnostic Test:
• Tone Audiometry
Evaluation of the participants' audiometrical thresholds
• Spectrotemporal Assessment
Evaluation of the participants' promptness in detecting a modulation of a harmonic complex
• Phoneme and Speech Perception
Evaluation of the participants' understanding of phonemes and short words, both in quiet and in noise
• Digit Triplet Test
Evaluation of the participants' ability to discern speech in noise

Other:
• Personalized fitting
Adjustment of the parameters of the participants' cochlear implants aimed at improving their speech perception

Behavioral:
• Personalized training
Self-administered training exercises focused on the speech components the participants are experiencing difficulties into

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Cochlear

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percent Speech Recognition	Given a list of CNC words, this score measures the percentage of correctly identified words.	Weeks 1, 10, 14, 18
Secondary	Change in Distance-based Accuracy Score	Speech Recognition accuracy score based on phoneme distance, such that mistaking a phoneme for a similar one such as mistaking /k/ for /g/ gives a lower penalty than mistaking a phoneme for a very different one.	Weeks 1, 10, 14, 18
Secondary	Change in Error Dispersion	Mathematical quantification of how much the errors made by the subjects are spread between stimuli and responses	Weeks 1, 10, 14, 18